Class II
Completed
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
This recall has been completed (originally issued March 13, 2019).
- Company
- Apotex Inc.
- Recall Initiated
- March 1, 2019
- Posted
- March 13, 2019
- Recall Number
- D-0992-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 82,705 cartons
- Firm Location
- North York, Canada
- Official Source
- View on FDA website ↗
Reason for Recall
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Distribution
Nationwide in the USA.
Lot / Code Info
Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020
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